Vaxcyte reports Q3 2026 results and positive Phase 3 data for VAX‑31
Vaxcyte announced that its VAX‑31 vaccine met all prespecified primary endpoints in the OPUS‑1 pivotal Phase 3 trial of 4,047 U.S. adults. The company said it will report results from the OPUS‑2 and OPUS‑3 trials in the first half of 2027 and plans to file a Biologics License Application in the first half of 2028. It also disclosed pro‑forma cash of about $3.4 billion as of September 30 2026, including roughly $1.1 billion raised from recent equity and convertible‑note offerings.
Why it matters
The trial success positions Vaxcyte to pursue a BLA for VAX‑31, potentially adding a best‑in‑class pneumococcal vaccine to the market. The strong cash position gives the company runway to fund the upcoming trials and a prospective U.S. launch. The earnings release shows a net loss of $297 million and EPS of $(1.99), reflecting higher R&D spending.
Key facts
- 1The OPUS‑1 trial evaluated VAX‑31 in 4,047 healthy, pneumococcal‑naïve U.S. adults. globenewswire.com
- 2VAX‑31 met all prespecified primary endpoints in the OPUS‑1 trial. globenewswire.com
- 3Vaxcyte expects to report OPUS‑2 and OPUS‑3 results in the first half of 2027. globenewswire.com
- 4The company plans to submit a Biologics License Application in the first half of 2028. globenewswire.com
- 5Pro‑forma cash, cash equivalents and investments were approximately $3.4 billion as of September 30 2026. globenewswire.com
- 6The recent equity and convertible senior notes offerings raised approximately $1.1 billion in net proceeds. globenewswire.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.